1. Technical Field
The invention relates to instruments for surgical correction of gastroesophageal reflux disease (GERD) and, more particularly, to surgical instrumentation and methods for performing non-invasive treatment of gastroesophageal reflux disease.
2. Background of the Related Art
Gastroesophageal reflux disease (GERD) is a common gastroesophageal disorder in which stomach contents leak into the lower esophagus due to a dysfunction of the lower esophageal sphincter. As a result, patients suffer numerous symptoms including heartburn, pulmonary disorders, and chest pain. Chronic GERD subjects the esophagus to ulcer formation, esophagitis, and numerous other complications. Advances in drug therapy for GERD include histamine receptor blockers (PEPCID.TM., ZANTAC.TM., etc.) which reduce stomach acid secretion and OMEPRAZOLE.TM. which may completely shut off stomach acid (achlorhydria). Although drugs may provide short term relief, drugs do not address the underlying problem of lower esophageal sphincter dysfunction.
Invasive procedures requiring percutaneous introduction of instrumentation to the operative site exist for the surgical correction of GERD. One such procedure, Nissen fundoplication, involves constructing a new "valve" to support the lower esophageal sphincter by wrapping the gastric fundus around the lower esophagus. Although the operation has a high rate of success. It is a major surgical procedure having the usual risks of abdominal surgery along with the intraoperative risk of perforation of the esophagus or of the cardia.
Efforts to perform Nissen fundoplication by less invasive techniques have resulted in the development of laparoscopic Nissen fundoplication. Laparoscopic Nissen fundoplication, reported by Dallemagne et al. Surgical Laparoscopy and Endoscopy, Vol. 1, No. 3, 1991, pp. 138-43 and by Hindler et al. Surgical Laparoscopy and Endoscopy, Vol. 2, No. 3, 1992, pp. 265-272, involves essentially the same steps as Nissen fundoplication with the exception that surgical manipulation is performed through a plurality of surgical cannulae introduced using trocars inserted at various position in the abdomen.
Another attempt to perform fundoplication by a less invasive technique is reported in U.S. Pat. No. 5,088,979 (Filipi et al.). In this procedure, an invagination device containing a plurality of needles is inserted transorally into the esophagus with the needles in a retracted position. The needles are extended to engage the esophagus and fold the attached esophagus beyond the gastroesophageal junction. A remotely operated stapling device, introduced percutaneously through an operating channel in the stomach wall, is actuated to fasten the invaginated gastroesophageal junction to the surrounding involuted stomach wall.
Although the above-described surgical procedures all provide the desired effect of supporting or bolstering the lower esophageal sphincter, all require surgical incisions of some kind to introduce the instruments necessary to perform the operation. Those that involve the use of needles within the esophagus also increase the danger of puncturing the esophagus.
A need in the art exists for the treatment of gastroesophageal reflux disease by fundoplication with an instrument system which is non-invasive. Such an instrument system could be used to perform the treatment without the need for any surgical incisions, permitting correction of the lower esophageal defect on an outpatient basis.